ArticleStatistics in biopharmaceutical research2018
An adaptive dose-finding design based on both safety and immunologic responses in cancer clinical trials.
Article in Statistics in biopharmaceutical research, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
6 citing papers in PubMed.
- Clinical Strategies for Enhancing the Efficacy of CAR T-Cell Therapy for Hematological Malignancies.Cancers · 2022Review
- Seamless phase I/II design for novel anticancer agents with competing disease progression.Statistics in medicine · 2021Article
- Chimeric antigen receptor T-cell therapies: Optimising the dose.British journal of clinical pharmacology · 2020Review
- Master protocols in immuno-oncology: do novel drugs deserve novel designs?Journal for immunotherapy of cancer · 2020Review
- Providing Patients with Critical or Life-Threatening Illnesses Access to Experimental Drug Therapy: A Guide to Clinical Trials and the US FDA Expanded Access Program.Pharmaceutical medicine · 2019Review
- Design considerations for early-phase clinical trials of immune-oncology agents.Journal for immunotherapy of cancer · 2018Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
Abstract
Dose-finding in cancer clinical trials has been dominated by algorithmic designs on the principle that the highest tolerable dose is also the most effective dose. This assumption no longer applies to the biologic treatments that are characterized by different toxicity and/or efficacy profiles to the extent that the best therapeutic dose might be well below any dose that produces serious toxicity. As such, we propose a two-stage design with focus on immunotherapy trials, incorporating both safety and efficacy information. The 1
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.